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A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients

Primary Purpose

Hepatitis B

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GC1102
GC1102 Placebo
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring GC1102, GC1102B, Chronic Hepatitis B virus, CHB, NAs, NUC

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who had this study information explained to them and understood it, voluntarily decided participation, and provided written consent
  • Patients who Aged ≥19 and ≤ 65 years at the time of signing the consent form
  • Patients with chronic hepatitis B who have been taking Nucleos(t)ide analogue antivirals 24 weeks before screening
  • Patients whose HBsAg and HBV DNA in blood; 10 IU/mL ≤ HBsAg titer ≤ 1,000 IU/mL and negative(-; below the limit of detection of 10 IU/mL) HBV DNA in the screening test

Exclusion Criteria:

  • Patients who have Hepatic diseases (e.g., autoimmune hepatitis) from causes other than hepatitis B
  • Patients who have history of liver transplantation, or liver transplantation schedule during the study
  • Patients who co-infected with HAV, HCV, HDV and HIV
  • Patient with Vasculitis
  • Patients who had a loss of blood or donated blood of ≥ 400mL within 8 weeks before the screening
  • patient who have active infection(other than chronic hepatitis B infection) requiring continual treatment with antibiotics or antivirals (except for clinically insignificant temporary infection such as cold)

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NAs antivirals + GC1102 180,000 IU

NAs antivirals + GC1102 Placebo

Arm Description

All patients are currently being treated with long-term NA treatment(more than 24 weeks) and will continue using these during the study. Each vial contains 1mL of study drug or placebo; Single IV bolus injection of 18mL V2 to V17 : IV bolus injection twice a week V18 to V33 : IV bolus injection once a week

All patients are currently being treated with long-term NA treatment(more than 24 weeks) and will continue using these during the study. Each vial contains 1mL of study drug or placebo; Single IV bolus injection of 18mL V2 to V17: IV bolus injection twice a week V18 to V33: IV bolus injection once a week

Outcomes

Primary Outcome Measures

Proportion of subjects with ≥ 1log10 reduction in HBsAg titer
HBsAg titer

Secondary Outcome Measures

Proportions of subjects with ≥ 0.5log10 reduction in HBsAg titer
HBsAg titer
Proportion of subjects with ≥ 1log10 reduction in HBsAg titer
HBsAg titer
Change in HBsAg titer
HBsAg titer
ALT response rates
Proportions of subjects with ALT ≤ 1.0 X ULN at Weeks 12, 24, 36 and 48 after the first dose of investigational product in subjects with ALT >1.0 X ULN at baseline
HBeAg seroconversion rates
Proportions of subjects with negative (-) HBeAg result at Weeks 12, 24, 36 and 48 after the first dose of investigational product in subjects with positive (+) HBeAg result at baseline
Rate of HBsAg loss
Proportions of subjects with negative (-; below the limit of detection of 0.5 IU/mL) HBsAg result at Weeks 24, 28, 36 and 48 after the first dose of investigational product
Proportion of negative (-; below the limit of detection of 10 IU/mL) HBV DNA at each measurement time point
Proportion of subjects with negative (-; below the limit of detection of 10 IU/mL) HBV DNA at each measurement time point

Full Information

First Posted
January 8, 2019
Last Updated
December 11, 2019
Sponsor
Green Cross Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03801798
Brief Title
A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients
Official Title
A Double-blind, Randomized, Placebo Controlled, Parallel-group, Phase 2a Study to Evaluate the Efficacy and Safety of GC1102 in Combination With Nucleos(t)Ide Analogues (NAs) in Patients With Chronic Hepatitis B
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of GC1102 in combination of Nucleo(t)ide analogues (NAs) in patients with chronic hepatitis B

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
GC1102, GC1102B, Chronic Hepatitis B virus, CHB, NAs, NUC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NAs antivirals + GC1102 180,000 IU
Arm Type
Experimental
Arm Description
All patients are currently being treated with long-term NA treatment(more than 24 weeks) and will continue using these during the study. Each vial contains 1mL of study drug or placebo; Single IV bolus injection of 18mL V2 to V17 : IV bolus injection twice a week V18 to V33 : IV bolus injection once a week
Arm Title
NAs antivirals + GC1102 Placebo
Arm Type
Placebo Comparator
Arm Description
All patients are currently being treated with long-term NA treatment(more than 24 weeks) and will continue using these during the study. Each vial contains 1mL of study drug or placebo; Single IV bolus injection of 18mL V2 to V17: IV bolus injection twice a week V18 to V33: IV bolus injection once a week
Intervention Type
Drug
Intervention Name(s)
GC1102
Intervention Description
NAs antivirals+GC1102 180,000 IU
Intervention Type
Other
Intervention Name(s)
GC1102 Placebo
Intervention Description
NAs antivirals+GC1102 Placebo
Primary Outcome Measure Information:
Title
Proportion of subjects with ≥ 1log10 reduction in HBsAg titer
Description
HBsAg titer
Time Frame
from baseline at Week 48 after the first dose of investigational product
Secondary Outcome Measure Information:
Title
Proportions of subjects with ≥ 0.5log10 reduction in HBsAg titer
Description
HBsAg titer
Time Frame
from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product
Title
Proportion of subjects with ≥ 1log10 reduction in HBsAg titer
Description
HBsAg titer
Time Frame
from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product
Title
Change in HBsAg titer
Description
HBsAg titer
Time Frame
from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product
Title
ALT response rates
Description
Proportions of subjects with ALT ≤ 1.0 X ULN at Weeks 12, 24, 36 and 48 after the first dose of investigational product in subjects with ALT >1.0 X ULN at baseline
Time Frame
from baseline at Weeks 12, 24, 36 and 48 after the first dose of investigational product
Title
HBeAg seroconversion rates
Description
Proportions of subjects with negative (-) HBeAg result at Weeks 12, 24, 36 and 48 after the first dose of investigational product in subjects with positive (+) HBeAg result at baseline
Time Frame
from baseline at Weeks 12, 24, 36 an 48 after the first dose of investigational product
Title
Rate of HBsAg loss
Description
Proportions of subjects with negative (-; below the limit of detection of 0.5 IU/mL) HBsAg result at Weeks 24, 28, 36 and 48 after the first dose of investigational product
Time Frame
from baseline at Weeks 12, 24, 28, 36 and 48 after the first dose of investigational product
Title
Proportion of negative (-; below the limit of detection of 10 IU/mL) HBV DNA at each measurement time point
Description
Proportion of subjects with negative (-; below the limit of detection of 10 IU/mL) HBV DNA at each measurement time point
Time Frame
from baseline at Weeks 3, 8, 12, 24, 36 and 48 after the first dose of investigational product

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who had this study information explained to them and understood it, voluntarily decided participation, and provided written consent Patients who Aged ≥19 and ≤ 65 years at the time of signing the consent form Patients with chronic hepatitis B who have been taking Nucleos(t)ide analogue antivirals 24 weeks before screening Patients whose HBsAg and HBV DNA in blood; 10 IU/mL ≤ HBsAg titer ≤ 1,000 IU/mL and negative(-; below the limit of detection of 10 IU/mL) HBV DNA in the screening test Exclusion Criteria: Patients who have Hepatic diseases (e.g., autoimmune hepatitis) from causes other than hepatitis B Patients who have history of liver transplantation, or liver transplantation schedule during the study Patients who co-infected with HAV, HCV, HDV and HIV Patient with Vasculitis Patients who had a loss of blood or donated blood of ≥ 400mL within 8 weeks before the screening patient who have active infection(other than chronic hepatitis B infection) requiring continual treatment with antibiotics or antivirals (except for clinically insignificant temporary infection such as cold)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Hoon Ahn, MD
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients

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